03
Aug

Rebecca (Becky) Welton, new Senior Associate in the Regulatory Practice at Lachman Consultants

We are pleased to announce that Rebecca Welton has accepted the position of Senior Associate in the Regulatory Practice at Lachman Consultants, effective August 3, 2020. Ms. Welton is an experienced Science, Operations and Regulatory leader with 25+ years in the pharmaceutical industry, holding positions of escalating accountabilities in chemistry, formulation, management, pilot plant, and […]

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01
May
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FDA Grants EUA for Remdesivir

No, this is not an approval, but it is an emergency use authorization to use the antiviral Remdesivir for COVID 19 patients.  The FDA issued this EUA on Friday, in record time, after positive results of the study involving Gilead’s drug.  The EUA will remain in effect until the COVID 19 public health emergency is […]

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16
Apr
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March 2020 Approval Actions, CRLs and Receipts and Update on Feb Metrics

Today OGD provided partial information for the typical first reported March Metrics and updated its February 2020 metrics.  Let’s start with the new March data. OGD reports 60 full approval actions and 17 tentative approval actions for a total of 77 approval actions for original applications in March, which is the highest number of total […]

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07
Apr
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How Do Bad Facts Become Fake News and Possibly Worse?

Oftentimes, we hear startling statistics that make us shiver and can cause a knee jerk reaction.  Much has been written about the quantity of drugs that come from overseas, and the push for moving manufacturing of active pharmaceutical ingredients (API) and finished dosage forms (FDF) back into the U.S.  While bringing jobs back to the […]

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06
Apr
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Let’s Face It! Protective Masks Have Revised Enforcement Policy Issued by CDRH

The Center for Devices and Radiological Health (CDRH) issued a revised guidance describing its policy on enforcement strategy for public personal use and filtered healthcare professional face masks titled Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (here).  The CDRH says the relaxed policy will remain in effect […]

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31
Mar
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FDA Promotes Hydroxychloroquine to Category 1 Status for Compounders – Wait a Minute!

My eyes almost popped out of my head when I read this article (here) concerning FDA’s move to place hydroxychloroquine in Category 1 for use by compounders based on a potential drug shortage created mostly by the administration’s hope that the drug may have some effect on COVID 19.  It is one thing to use […]

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